A Study of Adjuvant Chemoradiotherapy with Tri-weekly Cisplatin for Postoperative High-risk Oral Squamous Cell Carcinoma.

OBJECTIVE The aim of this study was to assess the feasibility and safety profile of concurrent chemoradiotherapy with cisplatin in Japanese patients with postoperative high-risk oral cancer. METHODS Patients with high-risk pathological features were selected from patients with oral squamous cell carcinoma who underwent surgery at the Department of Oral and Maxillofacial Surgery, Tokai University Hospital. Patients were given adjuvant chemoradiotherapy with tri-weekly cisplatin (100 mg/m2) (66 Gy/33 Fr), and the treatment completion rate was examined. RESULTS A total of 27 patients were enrolled between April 2011 and December 2012, including 19 males and 8 females. The median follow-up period was 36 months, and the protocol completion rate was 81.5%. Grade 3 or higher adverse events included leukopenia in 16 patients (59.3%), anemia in 7 patients (25.9%), mucositis in 2 patients (7.4%), increased creatinine in 1 patient (3.7%), nausea in 4 patients (14.8%), and anorexia in 12 patients (44.4%). The 3-year overall survival rate was 66.7%, relapse-free survival rate was 63.0%, and locoregional control rate was 77.8%. CONCLUSION The feasibility and safety profile of concurrent chemoradiotherapy with cisplatin in Japanese patients with postoperative high-risk oral cancer were comparable to pivotal phase III trials.